Whitepaper | Decoding AMDD & Accelerating Regulatory Compliance

Introduction

The Association of Southeast Asian Nations (ASEAN) is a regional grouping that aims to accelerate economic growth, social progress, cultural development, and security cooperation among its 10 members: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. ASEAN was founded on August 8, 1967. Medical device regulatory regimes are under the guidance of the ASEAN Economic Community (AEC). The ASEAN Consultative Committee on Standards and Quality (ACCSQ) was established in 1992 to remove technical trade barriers and facilitate an ASEAN free trade zone (AFTA). It established three harmonized regulatory regimes:

Agreement on ASEAN Harmonized Cosmetic Directive (ACD) (2003)
Agreement on ASEAN Harmonized Electrical and Electronic Regulatory Regime (AHEERR) (2005)
Agreement on ASEAN Medical Device Directive (AMDD) (2014)

AMDD aims to harmonize standards, technical regulations, and conformity assessment procedures.

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Overview of ASEAN MDD (AMDD)

The ASEAN Medical Device Directive (AMDD) was published in September 2015. It was signed and accepted by all member states. AMDD is a regional regulatory framework developed by the ASEAN to standardize the regulation of medical devices across member states. Recognizing the increasing importance of medical devices in healthcare delivery, the AMDD aims to ensure the safety, quality, and efficacy of medical devices while facilitating trade and harmonization within the ASEAN market.

Advantages of harmonization:

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ASEAN MDD Structure

The ASEAN MDD consists of 24 Articles and eight Annexes, as listed below.

Article	Provision	Description
Article 1	General Provisions	Authorized representative shall register the medical device with and be licensed by regulatory authority of member state.
Article 2	Definitions and Scope	Definitions and scope of the ASEAN MDD.
Article 3	Essential Principles of Safety and Performance of Medical Device	All medical devices shall meet Essential Principles of Safety and Performance (EPSP) of medical devices.
Article 4	Classification of Medical Devices	Medical devices to be classified (A, B, C, D) based on risk level.
Article 5	Conformity Assessment of Medical Devices	Medical devices shall be assessed by the regulatory authority/appointed bodies of member states, unless exempted by member states.
Article 6	Registration and Placement on the Market	Medical devices shall be assessed, registered, and marketed in the member states. Custom-devices are exempt.
Article 7	Licensing of Person Responsible for Placing Medical Device on the Markets of Member States	Member states are responsible for implementing appropriate licensing system.
Article 8	Technical Documents for Medical Devices	Annex 4 – Common Submission Dossier Template (CSDT); Annex 5 – Post Market Alert System (PMAS); and Annex 6 – Declaration of Conformity (DoC).
Article 9	Reference to Technical Standards	Medical devices shall conform to the standards of the ASEAN Medical Device Committee (AMDC) or standards accepted by regulatory authorities of member states.
Article 10	Labeling	Labelling will be done as per Annex 7 or as deemed appropriate by member states. Labeling may be required in national language of member states.
Article 11	Medical Device Claims	Medical Devices shall be subject to regulatory control of Member States.
Article 12	Post-Marketing Alert System (PMAS)	Distribution record, complaint record, Adverse Event Reporting (AER), Field Safety Corrective Action (FSCA).
Article 13	Clinical Investigation (CI)	Member states shall put in appropriate system for conduct of CI, considering Helsinki Declaration.
Article 14	Institutional Arrangements	The AMDC, ACCSQ, ASEAN secretariat, and AMDTC established by AMDC shall coordinate the implementation of the AMDD and shall comprise regulatory authorities of each member state.
Article 15	Safeguard Clauses	Member states shall acknowledge the safety of medical device placed in the market and in their own right terminate the placement of the medical device in case of compromise of safety and noncompliance.
Article 16	Confidentiality	Member states and parties involved in implementing this agreement are bound to observe confidentiality in handling and sharing information.
Article 17	Special Cases	Member states may register or prohibit placement of medical device/refurbished medical device, as they deem appropriate. The AMDD does not limit the authority of member states.
Article 18	Implementation	Member states shall implement the AMDD and shall ensure post market surveillance.
Article 19	Revisions, Modifications, and Amendments	This agreement can be revised, modified or amended, if all member states agree.
Article 20	Dispute Settlement	Mechanism to solve the disputes or disagreement among ASEAN member states.
Article 21	Reservations	Member states shall make no reservation with respect to any of the provisions of AMDD agreement.
Article 22	Entry into Force	January 2015.
Article 23	Annexes	Eight annexes are an integral part of the AMDD.
Article 24	Depositary	AMDD is accepted by all member states.

Annexes	Provision	Description
Annex 1	Essential Principles of Safety and Performance of Medical Device	19 Essential Principles of Safety and Performance (EPSP).
Annex 2	Risk Classification Rules for Medical Devices Other Than IVD Medical Devices	16 rules
Annex 3	Risk Classification Rules for IVD Medical Devices	7 rules
Annex 4	ASEAN Common Submission Dossier Template (CSDT)	Based on the Global Harmonization Task Force (GHTF) summary of technical documentation (STeD) format.
Annex 5	Post-Marketing Alert System (PMAS) Requirements	Import/distribution records, complaint records, Adverse Event (AE) reporting criteria and format, Field Safety Corrective Action (FSCA) reporting format.
Annex 6	Component Elements of Product Owner's or Physical Manufacturer's DoC	As per the details requested in this annex, template provided.
Annex 7	Labeling Requirements	Requirements for labels and Instruction for Use (IFU).
Annex 8	Clinical Investigation (CI)	Covers all requirements for CI, EPSP, Post Market Clinical Follow-up (PMCF).

Content of Technical Documentation (ASEAN CSDT)

The Common Submission Dossier Template (CSDT) has reduced the differences in documentation formats that existed in different ASEAN jurisdictions. The adoption of the CSDT in the ASEAN region has minimized the preparation of multiple dossiers, arranged in different formats but with essentially the same contents, for regulatory submission to various regulatory authorities within ASEAN.

Listed below are the contents of the ASEAN CSDT :

EU MDR vs. ASEAN MDD – A Quick Comparison

	EU MDR-2017/745	ASEAN MDD
Year of release	Regulation released in 2017	Directive released in 2015
Applicable to no. of countries/ regions	European Union, 27 countries	ASEAN, 10 countries
Articles in regulation/ directive	123 Articles	24 Articles
Annexes in regulation/ directive	16 Annexes	8 Annexes
Harmonized standards	Harmonized standards available	Harmonized standards available in ASEAN Trade Repository (https://atr.asean. org/index.php/standards/)
Device classification	Risk-based classification: Class I, II a, II b and III	Risk-based classification: Class A, B, C, D
Essential principles checklist	General Safety and Performance Requirements (GSPR)	Essential Principles of Safety and Performance (EPSP)
Submission document	Technical documentation	ASEAN Common Submission Dossier (CSD)

What is Embedded Software Testing?

The purpose of embedded software testing is to verify a software's functional and non-functional attributes as well as its bug-free integration with hardware. There are five levels of the testing process for embedded software:

1. Software unit testing

Software unit testing involves testing each unit of software to decide whether it performs as expected. The process involves isolating a section of code and verifying its accuracy during the software development phase. A unit may be a function, a module, an object, a procedure, or a method.

2. System unit testing

To conduct the test, a framework having information about software codes and real-time operating systems, including details about communication, mechanisms, and interrupts must be developed. A point of control protocol sends and receives messages via message queues. Next, the developer sees the system resources to figure out whether the system can accommodate embedded system execution. Gray box testing is often used for this process.

3. Integration testing

Integration testing can be further divided into two categories: software integration testing and software/hardware integration testing. A software component is tested in conjunction with a hardware component. You can also use this test to analyze how software interacts with peripheral devices. Embedded tests are always conducted in a real-world environment like the one in which software is developed. Most testers find embedded testing crucial since comprehensive testing can't be conducted under simulated conditions.

4. System integration testing

During this process, the entire system is contained within a single node. To control and observe, a combination
of communication protocol choice, operating system events, and messages is used. A combination of black and grey box testing is often used for this process.

5. System validation testing

This is also called acceptance testing. Here, testers ensure that the embedded system and subsystem are perfectly implemented. Analyzing whether the external entity can match the product's functional requirements is the main aim. External entities can be people, devices, or both. In this process, black box testing is often used.

Placing a Medical Device in the ASEAN Market

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Device Classification :

Determine the device classification: Medical devices are classified into four classes based on the risk levels of the devices as per their intended use.

• Class A – Low Risk

• Class B – Low-Moderate Risk

• Class C – Moderate-High Risk

• Class D – High Risk

Local Representative :

If applicable, appoint an authorized representative for local market (physical presence in ASEAN member states).

QMS Compliance :

Establish a quality management system as per ISO 13485.

Compile Technical Documentation :

Compile technical documentation as per CSDT.

Submission & full application review :

Submit application for device registration.

Appoint Importer :

If applicable, appoint a registered importer to bring the device into market.

Compliance Audit :

During audit compliance, regulatory authority verifies device classification and performs detailed classification of the submitted application.

Final Approval :

Regulatory authority grants final approval.

Product Launch :

Launch the product in ASEAN market.

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Comparative Analysis of Product Placement in the ASEAN, US, Europe, Japan, and Taiwan Markets

Market →	USA	Europe	Japan	ASEAN Countries					Non-ASEAN countries
General Information	US FDA	EU MDR	PMDA	Thailand	Philippines	Malaysia	Singapore	Vietnam	Taiwan
Regulatory Authority	US FDA Address: U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MID 20998	EU MDD	Pharmaceuticals and Medical Devices Agency (PMDA)	Thailand FDA Address: Ministry of Public Health, Food and Drug Administration, 88/24 Tiwanon Road, Nonthaburi, Thailand	Philippines FDA Republic of Philippine: Addrass: Civic Drive, Filinvest Corporate Cisy. Alabame. Muntiniupa, City	Malaysian Medical Device Authority (MDA) Address: Level 6, Prime 9. Medical Devices Granch Prima Avenue I1, Medical Devices Cluster Block 3547, Parsiaran APEC, Health Products Ragulation 63000 Cyberjaya, Selangor, Group; Health Sciences Malaysia	Health Science Authority (HAS) Medical Devices Branch Prima Avenue I1, Medical Devices Cluster Block 3547, Parsiaran APEC, Health Products Ragulation 63000 Cyberjaya, Selangor, Group; Health Sciences Malaysia Authority: 11 Biopolis Way, #11-03 Helios Singapara 138667	Department of Medical Equipments and Health Works (DMEHW) Addess: 138A Giang, Vo, Ba Dinh, Hanoi	Taiwan Food and Drug Administration (TFDA) Address: Main Office: No 161-2, Kunyang St, Nagang District, Taipei, 115-61, Taiwan (R.O.C)
Authorised Representative / Distributor Requirement	Applicable	Applicable	Applicable	Applicable	Applicable	Applicable	Applicable	Applicable	Applicable
Regulatory Guideline Requirement	1. US FDA, 510K guidance document for Industry and FDA staff	EU MDR-2017/745	Pharmaceuticals and Medical Devices Act (PMD Act)	1. Medical Device Act B.E. 2531 1998 2. EU MDR 3. US FDA 4. ASEAN MDD	1. AO2018-002, 2. EU MDR 3. US FDA 4. ASEAN MDD	1. Medical Device Regulation 2012 1998 2. EU MDR 3. US FDA 4. ASEAN MDD	1. Medical Device Guidance 2. EU MDR 3. US FDA 4. ASEAN MDD 5. PMD Act	Decree No. 169/2018/ND-CP (English translation required)	APEC Medical Devices Regulatory
Validity of Registration	Medical Device - 5 years	Medical Device - 5 years	Medical Device - does not expire	Medical Device - 5 years Import licence - 1 year	Medical Device - 5 years	Medical Device - 5 years	Medical Device - do not expire but registration fee shall be paid annually to maintain registration	1. Type A - unlimited 2. Type B, C & D - 5 years	Quality System Documentation - 3 years Product licence - 5 years
Duration of Registration submission	Class I, II, III - 90 days (510K submission)	Class I, IIa, IIb, III - Technical file submission to notified body which generally takes 40 to 60 days for review	Class I - (General Medical Device) < 1 month Class II (Specified Control Medical Device) 3-5 months, Class II (Specified Control Medical Device) 7-9 months, Class III (Highly Controlled Medical Device) 9-11 months, Class IV (Highly Controlled Medical Device) 13-16 months	Class I - (High Risk) - 8 to10 month Class II (Moderate Risk) - 6 to 8 months, , Class III (Low Risk) - 10 to 15 days	Class A - 1 month Class B, C & D - 3 to 6 months	Class A - 1 to 2 months Class B - 3 to 4 months Class C - 6 to 7 months Class D - 7 to 8 months	(For full route) Class A - NA Class B - 4 months Class C - 7 months Class D - 10 months Abridged submission takes around 5 months and is cost effective	1. Type A (Group 1) - 10 days 2. Type B, C & D (Group 2) - (a) 15 days (with national technical regulation) (b) 60 business days without national technical regulation and additional 15 days for supplement documentation needed	1. Class I - 1 to 2 months 2. Class II & III - 10 to 12 months
Language	English	English	Japanese	English & Thai language	English	English	English	English or Vietnamese	English or Chinese
Mode of Submission	Digital& Hard copy	Digital	Digital	Digital / Hard copy	Digital	Digital	Digital	Digital	Hard copy
Regulatory Complexity	Medium	High	Medium	Medium	Medium	Medium	Medium	Medium	Medium

Challenges Faced by Medical Devices Companies with ASEAN MDD Compliance

Ambiguity in interpretation of regulatory requirements for various ASEAN members states, leading to differences in documentation and submission requirements.
Submission of multiple dossiers for the same product for various ASEAN countries.
Variations in technical standards, labeling requirements, and clinical data expectations persist among member states, despite ASEAN MDD’s aim to harmonize regulatory requirements. Achieving full harmonization remains a challenge, requiring companies to navigate and comply with different sets of regulatory requirements.
Determining the appropriate classification of medical devices according to the ASEAN MDD guidelines, as different countries have different classification criteria and risk assessments, leading to variations in requirements for registration and conformity assessment.
Translating technical documentation, labels, and instructions for use into multiple languages to meet the requirements of each ASEAN member states is a huge challenge.
Implementing effective post-market surveillance systems to monitor the safety and performance of medical devices across ASEAN countries.
Timely reporting and addressing adverse events and complaints in multiple jurisdictions can be resource-intensive for medical device companies.
Limited infrastructure for evaluating medical devices, including testing laboratories, qualified personnel, and quality management systems. This can impact the efficiency and reliability of the regulatory process.

Accelerating Compliance to the ASEAN Market

The ASEAN Medical Device Directive plays a pivotal role in harmonizing the regulation of medical devices within the ASEAN region. By establishing common standards, classification systems, and conformity assessment procedures, the AMDD enhances patient safety, facilitates trade, and promotes regional integration. While challenges exist in its implementation, the AMDD offers significant opportunities for manufacturers, regulators, and healthcare providers in ASEAN, fostering a more robust and harmonized medical devices market in the region. Cyient offers a one-stop solution for helping medical device companies comply with the ASEAN MDD as well as ASEAN country-specific regulatory requirements. Cyient also offers CyARC (Cyient Accelerated Regulatory Platform) to help accelerate compliance to the ASEAN market. Empowered by our Quality Assurance and Regulatory Affairs (QARA) CoE, Cyient has certified professionals across all functions who have the required skill sets and expertise to support medical device companies in placing their medical devices on ASEAN market.

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About the Author

Abhishek Kumar is an SME in medical device regulatory and quality assurance services. With 12+ years of experience, he has successfully led multiple engagement programs for US, Europe, China, and ASEAN markets for NPD and sustenance. Additionally, Abhishek has prepared and implemented the regulatory plan for NPD for 90+ countries by analyzing project feasibility, freezing regulatory requirements, and coordinating with various cross-functional teams.

About Cyient

Cyient (Estd: 1991, NSE: CYIENT) is a global Engineering and Technology solutions company. We collaborate with our customers to design digital enterprises, build intelligent products and platforms and solve sustainability challenges. We are committed to designing tomorrow together with our stakeholders and being a culturally inclusive, socially responsible, and environmentally sustainable organization.

For more information, please visit www.cyient.com

Decoding the ASEAN Medical Device Directive (AMDD) and Accelerating Regulatory Compliance for the ASEAN Market AMDD aims to harmonize standards, technical regulations, and conformity assessment procedures in the ASEAN region.

Abstract

Introduction

Overview of ASEAN MDD (AMDD)

ASEAN MDD Structure

Content of Technical Documentation (ASEAN CSDT)

EU MDR vs. ASEAN MDD – A Quick Comparison